Manage medical case processing and evaluate adverse events, review and triage ICSRs from clinical trials, author PSURs for regulatory submissions, detect safety signals, and perform risk-benefit evaluations to ensure regulatory compliance and patient safety.
- The Team You Will Join: The Global Medical Safety and Regulatory Affairs division serves as the clinical conscience of our organization, actively protecting patient safety globally throughout the drug lifecycle.
- The Opportunity: Seeking a Drug Safety Specialist to manage medical case processing, evaluate adverse events, and ensure regulatory compliance.
- Key Responsibilities:
- Review, triage, and medically evaluate Individual Case Safety Reports (ICSRs) from clinical trials.
- Author Periodic Safety Update Reports (PSURs) for submission to global health authorities.
- Detect signal trends and conduct risk-benefit evaluations on marketed therapies.
- Required Qualifications: Degree in a Healthcare or Life Sciences discipline (RN, B.Pharm, PharmD, or MD preferred); 3–5 years of pharmacovigilance experience; proficiency with safety databases (Argus/ArisGlobal).
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